About the study - Myelofibrosis Treatment | UniSC | University of the Sunshine Coast, Queensland, Australia

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About the study - Myelofibrosis Treatment

Thank you for registering your interest in our myelofibrosis study. A member of the research team will be in touch within 2 business days to go through the study with you.

What is the study for?

This study is for people 18 years of age or older with myelofibrosis, who have never received treatment with a JAK inhibitor, such as ruxolitinib (Jakavi), fedratanib, momelotinib, pacritinib, or baricitinib (Olumiant).

The study is a Phase 3 clinical trial to assess whether the clinical trial medication CPI-0610 (pelabresib), in combination with ruxolitinib, can improve outcomes for people with myelofibrosis compared to treatment with ruxolitinib alone.

What's involved?

• An up to 28-day screening period
• 21-day study treatment cycles for up to 36 months
• MRI or CT scan every 12 weeks
• Blood tests at multiple visits
• A bone marrow biopsy every 24 weeks until week 72, then every 48 weeks thereafter

This is an active-control, double blind study. This means there is a 50% chance you will receive ruxolitinib with the study medication pelabresib, and a 50% chance you will receive ruxolitinib with a placebo instead of the study medication. A placebo is a harmless pill looks like CPI-0610 but has no medication. Neither you nor the study staff will know which treatment you receive.

The research team will sit down with you and go through the study criteria, as well as your medical history, current and past medications and vaccinations. There will be some blood tests and medical examinations to help determine your eligibility for the study.

You will be required to present a valid form of ID at each visit.

All study procedures are at no cost to you, and you will be reimbursed for expenses related to study participation.

NOTE: Pelabresib is an investigational new drug and not yet approved by any regulatory authority.

Where can I find more information?

More information can be requested by contacting the research site to the right. Alternatively, the research team will be more than happy to answer any questions you may have when they call.

Full Title: A phase 3, randomized, double-blind, active-control study of CPI-0610 and Ruxoltinib vs. Placebo and Ruxolitinib in JAKi treatment naïve MF patients.

HREC Approval: Bellberry Human Research Ethics Committee